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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Glucose Oxidase, Glucose
510(k) Number K133584
Device Name IN TOUCH BLOOD GLUCOSE MONITORING SYSTEM
Applicant
Eoshealth, Inc.
816 Congress Ave. Suite 1400
Austin,  TX  78701
Applicant Contact Carrie Hetrick
Correspondent
Eoshealth, Inc.
816 Congress Ave. Suite 1400
Austin,  TX  78701
Correspondent Contact Carrie Hetrick
Regulation Number862.1345
Classification Product Code
CGA  
Subsequent Product Codes
JJX   NBW  
Date Received11/21/2013
Decision Date 09/08/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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